IMPLANTABLE PACEMAKER LEADS
FDA premarket approval P860007/S021 · decided 1999-12-02
Approval details
- PMA number
- P860007
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- IMPLANTABLE PACEMAKER LEADS
- Generic name
- PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
- Applicant
- Boston Scientific
- Date received
- 1999-10-25
- Decision date
- 1999-12-02
- Days to decision
- 38 days
- Decision code
- APPR
- Product code
- LWW
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the manufacturing and labeling facility located at Guidant Corp., St. Paul, MN 55112-5798.
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