DILAPAN(TM)
FDA premarket approval P840045/S002 · decided 1988-09-28
Approval details
- PMA number
- P840045
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DILAPAN(TM)
- Generic name
- dilator, cervical, synthetic, osmotic, pregnancy termination
- Applicant
- Medicem Technology S.R.O
- Date received
- 1987-08-04
- Decision date
- 1988-09-28
- Days to decision
- 421 days
- Decision code
- APPR
- Product code
- LOB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Kamenne Zehrovice
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Dilapan-S (K143447) | Medicem Technology S.R.O | 2015-04-17 |