Question 1

What types of medical devices does Synovis Life Technologies, Inc. manufacture?

Accepted Answer

Synovis Life Technologies, Inc. specializes in bioabsorbable and collagen-based surgical products. Their portfolio includes staple line-reinforcement strips and gels designed to strengthen tissue, animal-derived cardiovascular patches and dura mater grafts for reconstructive procedures, and intravascular devices like single-use probes, anastomosis occluders, and surgical shunts. They also produce extra-gynaecological surgical meshes made from collagen, which are intended for specific surgical applications.

Question 2

Where is Synovis Life Technologies, Inc. based?

Accepted Answer

Synovis Life Technologies, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under U.S. medical device regulations, including those enforced by the FDA.

Question 3

How are Synovis Life Technologies, Inc.’s devices classified by the FDA?

Accepted Answer

Synovis Life Technologies, Inc.’s devices are classified under FDA Class II. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance. Class II devices are authorised through pathways like the 510(k) Premarket Notification or the De Novo process.

Question 4

Which regulatory registries or databases list Synovis Life Technologies, Inc.’s devices?

Accepted Answer

Synovis Life Technologies, Inc.’s devices are listed in the FDA’s regulatory databases, specifically the 510(k) Premarket Notification database and the Unique Device Identifier (UDI) system. These registries help track and monitor devices authorised for commercial distribution in the U.S., ensuring transparency and compliance with regulatory requirements.

Question 5

Why are Synovis Life Technologies, Inc.’s devices authorised through the 510(k) and De Novo pathways?

Accepted Answer

The 510(k) pathway is used for devices that are substantially equivalent to legally marketed predicates, demonstrating they meet the same safety and performance standards. The De Novo pathway is reserved for low-to-moderate-risk devices with no legally marketed predicate, allowing the FDA to classify them as Class II after reviewing their safety and effectiveness data. Synovis’s devices, such as staple line-reinforcement strips and intravascular occluders, fall under these pathways due to their specific risk profiles and intended uses.

Device	Model / Reference	Registries	Class	Status
Vascular Probe Extra Supple	7081520ES	FDA UDI	Class II	Active
Flo-Thru Intraluminal Shunt®	FT-12125	FDA UDI	Class II	Active
Flo-Rester® Disposable Internal Vessel Occluder	60175	FDA UDI	Class II	Active
Vascu-Guard	VG0114	FDA UDI	Class II	Active
Peri-Guard	PC1225N	FDA UDI	Class II	Active
Supple Peri-Guard	SPG0608	FDA UDI	Class II	Active
Peri-Strips Dry with Veritas Collagen Matrix Circular	PSD21EV	FDA UDI	Class II	Unknown
Peri-Strips Dry with Veritas Collagen Matrix	PSD4502ECHV	FDA UDI	Class II	Unknown
Peri-Strips Dry with Veritas Collagen Matrix	PSD4506ETSV	FDA UDI	Class II	Active
VASCU-GUARD Peripheral Vascular Patch	VG0106N	FDA UDI	Class II	Active
Peri-Strips Dry with Veritas Collagen Matrix	PSD6002UDSTV	FDA UDI	Class II	Unknown
Vascular Probe Extra Supple	7082025ES	FDA UDI	Class II	Active
Veritas Collagen Matrix	RM-0416	FDA UDI	Class II	Active
Peri-Strips Dry with Veritas Collagen Matrix	PSD6006UV	FDA UDI	Class II	Active
DURA-GUARD Dural Repair Patch	DG0608SN	FDA UDI	Class II	Active
Flo-Rester® Disposable Internal Vessel Occluder	60275	FDA UDI	Class II	Active
Peri-Strips Dry with Veritas Collagen Matrix	PSD6006UV	FDA UDI	Class II	Active
Vascular Probe Extra Supple	7151520ES	FDA UDI	Class II	Active
Peri-Strips Dry with Veritas Collagen Matrix	PSD7502EV	FDA UDI	Class II	Unknown
Veritas Collagen Matrix	RM-1212	FDA UDI	Class II	Active
Flo-Rester® Disposable Internal Vessel Occluder	50225	FDA UDI	Class II	Active
Peri-Strips Dry with Veritas Collagen Matrix	PSD6002UV	FDA UDI	Class II	Unknown
Peri-Strips Dry with Veritas Collagen Matrix	PSD9002PIV	FDA UDI	Class II	Unknown
Peri-Strips Dry with Veritas Collagen Matrix	PSD4502ETSV	FDA UDI	Class II	Unknown
Supple Peri-Guard	PC0814SN	FDA UDI	Class II	Active
Flo-Thru Intraluminal Shunt®	FT-12200	FDA UDI	Class II	Active
Peri-Strips Dry with Veritas Collagen Matrix	PSD6006ECHV	FDA UDI	Class II	Active
Peri-Guard	PG0404	FDA UDI	Class II	Active
Peri-Strips Dry with Veritas Collagen Matrix	PSD4502ECHV	FDA UDI	Class II	Unknown
Flo-Rester® Disposable Internal Vessel Occluder	60125	FDA UDI	Class II	Active
Flo-Rester® Disposable Internal Vessel Occluder	50200	FDA UDI	Class II	Active
Peri-Strips Dry with Veritas Collagen Matrix	PSD6006UDSTV	FDA UDI	Class II	Active
Peri-Guard	PG0608	FDA UDI	Class II	Active
Peri-Strips Dry with Veritas Collagen Matrix Circular	PSD25EV	FDA UDI	Class II	Unknown
Flo-Rester® Disposable Internal Vessel Occluder	50250	FDA UDI	Class II	Active
Supple Peri-Guard	PC1016SN	FDA UDI	Class II	Active
Peri-Strips Dry with Veritas Collagen Matrix	PSD4506EV	FDA UDI	Class II	Active
Supple Peri-Guard	SPG0406	FDA UDI	Class II	Active
Peri-Strips Dry with Veritas Collagen Matrix	PSD8006UDSTV	FDA UDI	Class II	Active
Peri-Strips Dry With Veritas Collagen Matrix Circular	PSD21V	FDA UDI	Class II	Active
Supple Peri-Guard	PC0608SN	FDA UDI	Class II	Active
Peri-Strips Dry with Veritas	PSDA45GIA	FDA UDI	Class II	Active
Veritas Collagen Matrix	RM-0608	FDA UDI	Class II	Active
Peri-Strips Dry with Veritas Collagen Matrix	PSD4506UV	FDA UDI	Class II	Active
Vascular Probe Extra Supple	7152025ES	FDA UDI	Class II	Active
Vascu-Guard	VG0209	FDA UDI	Class II	Active
Peri-Strips Dry With Veritaswith Secure Grip	PSDA60ECH	FDA UDI	Class II	Active
Peri-Strips Dry with Veritas Collagen Matrix	PSD7506EV	FDA UDI	Class II	Active
Veritas Collagen Matrix	RM-0818	FDA UDI	Class II	Active
Peri-Strips Dry with Veritas Collagen Matrix	PSD4506ECHV	FDA UDI	Class II	Active

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