RELIANCE URINARY CONTROL INSERT & SIZING DEVICE
FDA premarket approval P960020/S001 · decided 1999-04-01
Approval details
- PMA number
- P960020
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- RELIANCE URINARY CONTROL INSERT & SIZING DEVICE
- Generic name
- Transurethral occlusion insert, urinary incontinence-control, female
- Applicant
- Uromed Corp.
- Date received
- 1999-03-17
- Decision date
- 1999-04-01
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- OCK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Needham, MA
- Statement
- Approval for suspension of postapproval study because company is discontinuing manufacture and distribution of device.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO CAVERMAP SURGICAL AID (K010213) | Uromed Corp. | 2001-04-20 |
| MODIFICATION TO CAVERMAP SURGICAL AID (K010098) | Uromed Corp. | 2001-02-01 |
| CAVERMAP SURGICAL AID (K000507) | Uromed Corp. | 2000-04-21 |
| CAVERMAP SURGICAL AID (K993436) | Uromed Corp. | 2000-02-11 |
| UROMED BRACHYTHERAPHY IODINE-125 SOURCES (K982226) | Uromed Corp. | 1999-05-13 |
| UROMED SLING KIT (K980717) | Uromed Corp. | 1998-05-22 |
| UROMED PATCH (K974600) | Uromed Corp. | 1998-03-31 |
| UROMED NEEDLE GRASPER (K974137) | Uromed Corp. | 1998-01-30 |