MCGHAN MEDICAL SALINE-FILLED BREAST IMPLANTS
FDA premarket approval P990074/S008 · decided 2001-08-08
Approval details
- PMA number
- P990074
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MCGHAN MEDICAL SALINE-FILLED BREAST IMPLANTS
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Allergan
- Date received
- 2001-07-23
- Decision date
- 2001-08-08
- Days to decision
- 16 days
- Decision code
- OK30
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGE IN MANUFACTURING METHOD. THE CHANGE ADDS AN ALTERNATIVE METHOD FOR A CASTING PROCESS USING THE MOLDING METHOD OF THE STYLE 68 SALINE-FILLED BREAST IMPLANT SHELL COMPONENT USED IN THE FABRICATION OF SALINE-FILLED BREAST IMPLANTS. THERE WILL BE NO CHANGES TO COMPONENT SPECIFICATIONS, DESIGNED PERFORMANCE SPECIFICATIONS OF THE FINISHED DEVICE, OR TO THE PMA DESIGNATED PHYSICAL AND CHEMICAL SPECIFICATIONS OF THE FINISHED DEVICE.
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510(k) clearances by this applicant
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|---|---|---|
| NATRELLE INSPIRA Single Use Sizers for Gel Implants (K203229) | Allergan | 2021-06-02 |
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| Natrelle 133S Tissue Expander (K182054) | Allergan | 2018-08-29 |
| TrueTear Intranasal Tear Neurostimulator (DEN170086) | Allergan | 2018-05-17 |
| SERI SURGICAL SCAFFOLD (K123128) | Allergan | 2013-04-25 |