THINLINE/FINELINE
FDA premarket approval P960004/S008 · decided 1999-09-27
Approval details
- PMA number
- P960004
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- THINLINE/FINELINE
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 1999-08-31
- Decision date
- 1999-09-27
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the alternate manufacturing facility located at Guidant Puerto Rico, No. 12 Road No. 698, Dorado, Puerto Rico 00646 and the alternate sterilization facility located at COSMED of Illinois, 1160 Northpoint Blvd., Waukegan, Illinois 60085.
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