RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE
FDA premarket approval P960020 · decided 1996-08-16
Approval details
- PMA number
- P960020
- Trade name
- RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE
- Generic name
- Transurethral occlusion insert, urinary incontinence-control, female
- Applicant
- Uromed Corp.
- Date received
- 1995-08-18
- Decision date
- 1996-08-16
- Days to decision
- 364 days
- Decision code
- APPR
- Product code
- OCK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- Yes
- Location
- Needham, MA
- Statement
- APPROVAL FOR THE RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |