Prentif Cavity Rim Cervical Cap
PMA P870062
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP870062 | Date23 May 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Prentif Tm Cavity Rim Cervical Cap
- Generic Name
- Cap, cervical, contraceptive
- FDA applicant
- Lamberts Dalston , Ltd.
- PMA Number
- FDA Product Code
- LLQ
- Device Class
- Class III
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Prentif Cavity Rim Cervical Cap is a cervical contraceptive cap designed to prevent pregnancy by blocking sperm entry into the cervix. It is classified under the generic name 'Cap, cervical, contraceptive' and is intended for use as a barrier method of contraception.
Supplied by Lamberts Dalston Ltd., this device received FDA Premarket Approval (PMA) under number P870062 on May 23, 1988. It is a Class III medical device with product code LLQ and was registered under FEI numbers 3002764647 and 3003270419. The device is non-sterile, reusable, and intended for clinical use in obstetrics and gynecology settings.
Questions
AI-generated answers, 18 Sep 2026
What type of device is the Prentif Cavity Rim Cervical Cap?
The Prentif Cavity Rim Cervical Cap is a cervical contraceptive cap, classified as a Class III medical device under the generic name 'Cap, cervical, contraceptive'. It functions as a barrier method to prevent sperm from entering the cervix, thereby providing contraception.
Is the Prentif Cavity Rim Cervical Cap approved by the FDA?
Yes, the Prentif Cavity Rim Cervical Cap received FDA Premarket Approval (PMA) under application number P870062, with the decision date of May 23, 1988, and the approval was published in the Federal Register on July 19, 1988.
Who manufactures the Prentif Cavity Rim Cervical Cap and where are they located?
The device is manufactured by Lamberts Dalston Ltd., located at Dalston House, Hastings St., Luton, Beds., LU1 5BW, United Kingdom, as indicated in the manufacturer address fields within the device data.