6616
6616 is a Class III device made by Boston Scientific, approved under FDA PMA P960006 on 2 Oct 1998 and listed in FDA GUDID since 24 Sep 2014 (UDI-DI 00802526489419), active as of 22 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00802526489419 | Date24 Sep 2014 | StatusListed |
| United States | FDA PMAAPPR | NumberP960006 | Date2 Oct 1998 | StatusActive |
Official records
- AccessGUDID record 00802526489419
- FDA PMA database P960006
Across registries
- FDA PMA P960006 decided 2 Oct 1998 Active
- FDA GUDID UDI-DI 00802526489419 listed 24 Sep 2014 Listed
Timeline
- Approved FDA PMA P960006
- Listed FDA GUDID 00802526489419
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic name
- Endocardial/interventricular septal pacing lead
- Model / reference
- 6616
- Primary DI / UDI-DI
- 00802526489419
- PMA number
- FDA product code
- DTB
- GMDN term
- Endocardial/interventricular septal pacing lead
- Device class
- Class III
- Regulation number
- 870.3680
- GUDID distribution status
- In Commercial Distribution
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