FEMSOFT URETHRAL INSERT
FDA premarket approval P990002/S002 · decided 2013-03-21
Approval details
- PMA number
- P990002
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FEMSOFT URETHRAL INSERT
- Generic name
- Transurethral occlusion insert, urinary incontinence-control, female
- Applicant
- Rochester Medical Corp.
- Date received
- 2012-12-26
- Decision date
- 2013-03-21
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- OCK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Stewartville, MN
- Statement
- APPROVAL FOR LABELING MODIFICATIONS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HYDROSIL; MAGIC; PERSONAL CATHETER (K122785) | Rochester Medical Corp. | 2013-05-14 |
| HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT (K033477) | Rochester Medical Corp. | 2004-06-10 |
| RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER (K001143) | Rochester Medical Corp. | 2000-07-07 |
| HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) (K000723) | Rochester Medical Corp. | 2000-05-19 |
| ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER (K981612) | Rochester Medical Corp. | 1998-07-08 |
| SILICONE ANTIBACTERIAL FOLEY CATHETER (K971627) | Rochester Medical Corp. | 1998-01-13 |
| PERSONAL CATHETER (K970704) | Rochester Medical Corp. | 1997-03-13 |
| ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER (K952082) | Rochester Medical Corp. | 1995-07-18 |