MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU
FDA premarket approval P840051/S003 · decided 1989-06-07
Approval details
- PMA number
- P840051
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU
- Generic name
- Suture, absorbable, synthetic, polyglycolic acid
- Applicant
- Davis & Geck, Inc.
- Date received
- 1989-05-15
- Decision date
- 1989-06-07
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- GAM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Danbury, CT
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 |
|---|---|---|
| SILK SUTURE (K982853) | Davis & Geck, Inc. | 1999-04-30 |
| SURGILON, DERMALON, & OPHTHALON (K981582) | Davis & Geck, Inc. | 1998-07-13 |
| ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL (K974015) | Davis & Geck, Inc. | 1998-05-18 |
| DEXON RAPID (DEXON R) (K980610) | Davis & Geck, Inc. | 1998-05-18 |
| MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE (K980062) | Davis & Geck, Inc. | 1998-03-20 |
| KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS (K973409) | Davis & Geck, Inc. | 1998-02-27 |
| ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO (K970857) | Davis & Geck, Inc. | 1997-11-05 |
| ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP (K972139) | Davis & Geck, Inc. | 1997-09-03 |